A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
NCT05039619
This study is recruiting at 9 US sites in 8 states, according to its ClinicalTrials.gov record last updated .
Summary
This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to <12 with LN.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Lupus Nephritis
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 2
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Hoffmann-La Roche
- Last updated on ClinicalTrials.gov
- October 6, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 2
- Loma Linda University health · Loma Linda, CA
- UCSF Benioff Childrens Hospital · San Francisco, CA
Colorado · 1
- Children's Hospital Colorado, Anchutz Medical Campus · Aurora, CO
Georgia · 1
- Emory Children's Center · Atlanta, GA
Indiana · 1
- Indiana University Health University Hospital · Indianapolis, IN
Louisiana · 1
- Louisiana State University · Shreveport, LA
New Jersey · 1
- Hackensack University Medical Center · Hackensack, NJ
New York · 1
- Cohen Children's Medical Center of New York · Queens, NY
Ohio · 1
- Cincinnati Childrens Hospital · Cincinnati, OH
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.